NCT05451680

Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg

A Randomized Study on the Effect of Negative-pressure Wound Therapy on Below-the-knee Skin Cancer Graft Reconstruction Complications

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

Detailed description

Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.

Conditions

• Skin Tumor

Interventions

Type	Name	Description
DEVICE	Negative pressure device	Negative-pressure therapy postoperatively on the full-thickness skin graft
PROCEDURE	Conventional care	Conventional dressing postoperatively on the full-thickness skin graft

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-01-01
• Completion: 2024-07-01
• First posted: 2022-07-11
• Last updated: 2023-11-21

Locations

1 site across 1 country: Finland